Rally #188-1-2321
Quidel #20321
Fluorescent Immunoassay Analyzer Sofia® 2 CLIA Waived
STARTUP KIT, STREP A+ W/ANALYZER/INSTALL PK D/S
(1/KT)
Contents
(1) Leased Analyzer, (1) Install Pack, (3) Strep A Kits
Quidel™ Sofia™ 2 Fluorescent Immunoassay Analyzer (1) [20299]
Features
- User interface: Intuitive, fast and easy-to-use interface allows operators to quickly run patient samples or navigate stored data.
- Objective, automated results: Eliminates operator to operator variability often associated with interpreting visually-read test results. Results are displayed on-screen, printed to an external printer, and/or sent to Virena effortlessly.
- Data Management: Results can be reported and stored in multiple ways to meet your data management needs.
- Fluorescent technology: Optimized performance
- Two development modes: Offers flexibility by accommodating specific workflow demands
- Walk away automation: No need for operator to wait for results
- Security: Offers supervisors the ability to set access rights by operator to prevent unauthorized use or use by untrained operators
- Barcode technology: Reduce time and errors associated with manually recording patient and operator ID
- Virena™ Connectivity: Reduce time manually recording test results
- Li Po rechargeable Battery: Can be used anywhere testing needs to be done
Product Specifications
Dimensions (D x W x H) | 22 x 12 x 12cm |
Weight | 2 lb. (1kg) |
Power supply input | 100-240 VAC, 50-60 Hz, self-switching (U.S./ International), 2.93 |
Analyzer input | 7.5V DC 2.5A |
Replacement battery | Li Po rechargeable |
Display | 4-inch color LCD touchscreen |
LAN interface | RJ45 connector |
Operating temperature | 15°C to 30°C/59°F to 86°F |
Operating humidity | 20% to 85% RH non condensing |
Operating altitude | 2000 m maximum |
Shipping and storage temperature | −20°C to 55°C |
Shipping and storage humidity | 20% to 85% RH non condensing |
Patient test result storage | 1000 tests maximum |
QC results storage | 200 results maximum |
Calibration results storage | 200 results maximum |
Sofia® Strep A + FIA (3 x 25 Tests) [20274]
Features
- For use with Sofia Analyzer
- CLIA-Waived
- Highly sensitive and specific with enhanced assay accuracy
- Analyzes and provides objective result versus visually read tests
- Involves antigenic components extraction of Group A Streptococcus (GAS) bacteria
- Results in 5 minutes
- Self-contained cassette that is easy to use and dispose
- Fixed volume pipette for correct amount of sample
- All components included in the kit
(25) Individually Packaged Cassettes, (25) Reagent Tubes, (25) Reagent Solution, (25) Sterile Rayon Throat Swabs, (25) Fixed Volume Pipettes, Positive Control Swab, Negative Control Swab, Printer Paper, Package Insert, Quick Reference Instructions.
The Sofia® Strep A+ Fluorescent Immunoassay (FIA) uses advanced immunofluorescence–based lateral–flow technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. It is for use with Sofia® 2 and Sofia® Analyzers.
Product Specifications
Sample type | Throat swab |
Time to results | 5 minutes |
Kit storage conditions | Room temperature (15°C to 30°C/59°F to 86°F) |
Internal controls | Positive and negative |
Sensitivity | 93.7% |
Specificity | 94.4% |
Shelf life | 24 months from date of manufacture |
CLIA complexity | Waived |
Weight (Pounds) | 1.05 |
Sofia 2 Fluorescent Immunoassay Analyzer Documentations - 20299 (1 Unit)
- FAQ - Sofia 2 Analyzer Automatic Updates FW 1.12 or higher
- FAQ - Sofia 2 Fluorescent Immunoassay Analyzer
- Installation Instructions - Sofia 2 Fluorescent Immunoassay Analyzer
- QuickStart Guide - Sofia 2 Fluorescent Immunoassay Analyzer
- QuickStart Guide - Sofia 2 Fluorescent Immunoassay Analyzer FW 1.12 or higher
- SDS - Sofia 2 Fluorescent Immunoassay Analyzer
- Sales Sheet - Sofia 2 Fluorescent Immunoassay Analyzer
- Technical Bulletin - Accessing Patient Data
- Technical Bulletin - Firmware Update 1.12
- Technical Bulletin - Firmware Update 1.13
- Technical Bulletin - Firmware Update 1.14
- Technical Bulletin - Firmware Update 1.15
- Technical Bulletin - Firmware Update 1.15.2
- Technical Bulletin - Running External QC
- User Manual - Sofia 2 Fluorescent Immunoassay Analyzer FW 1.12 or higher
- User Manual - Sofia 2 Fluorescent Immunoassay Analyzer